MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim.
[104870436]
No fluoro after software upgrade. After mandatory sedecal integrated console flash card upgrade, the fluoro is not working intermittently the default configuration step was not performed and so the sedecal was in rad only mode instead of r/f. Even after performing this step, the system still will not fluoro. Cycle power on the gim box to no avail. Nothing wrong upon checking the service mode at the generator interface settings. No interlocks indicated at the table or sedecal. Rotor does kick on, but no fluoro is produced. Patient was moved to another room to finish. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00009 |
| MDR Report Key | 7398815 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-03-08 |
| Device Manufacturer Date | 2011-11-30 |
| Date Added to Maude | 2018-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E. GALBRAITH RD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUT EXT DR FINAL ASSY-REVERSE |
| Generic Name | HUT EXT DR FINAL ASSY-REVERSE |
| Product Code | IXR |
| Date Received | 2018-04-05 |
| Model Number | 404007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E. GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-05 |